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ADL5945 · 2 trials · 2 indications
An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). |
| ADL5945 0.25 mg | EXPERIMENTAL | During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. |
| ADL5945 0.1 mg | EXPERIMENTAL | During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| ADL5945 0.25 mg | DRUG | - |
| ADL5945 0.1 mg | DRUG | - |
Key Inclusion Criteria * be a man or woman aged 18 to 75 years, inclusive, at the time of screening * have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per square meter (kg/m\^2) * be taking a stable daily dose of opioids of ≥30-milligrams (mg) morphine-equivalent tota...
ADL5945 is an investigational small molecule being developed for the treatment of constipation and opioid-induced constipation in adults taking opioid therapy for chronic noncancer pain. It is currently in Phase 2 clinical development and is not approved by the FDA.
ADL5945 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The drug is currently in Phase 2 clinical trials for gastrointestinal conditions, specifically constipation and opioid-induced constipation.
ADL5945 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for the drug have been completed, and it is being studied for the treatment of opioid-induced constipation.
ADL5945 has been studied in two completed Phase 2 clinical trials: NCT01207427, which evaluated its efficacy and safety for opioid-induced constipation in 131 adults, and NCT01275755, which evaluated once-daily dosing for constipation in 81 adults. Both trials were randomized, double-blind, and placebo-controlled.
No alternative names for ADL5945 have been disclosed. The drug is identified solely by its code name ADL5945 in clinical trials and is being developed by Merck & Company, Inc. for the treatment of opioid-induced constipation.